Medical needle safety apparatus and methods

ABSTRACT

Parts which may be integrally molded with a phlebotomy barrel or with a Luer fitting to provide, in a single molded part, an extendable safety enclosure for a medical cannula in phlebotomy, syringe and other general medical needle applications. Integrally molded part phlebotomy safety devices are disclosed which require only the integrally-molded part, a medical needle, a label and a transport needle cover to form a ready-to-use phlebotomy device. Upon removal of the label and needle cover, the device is ready for use in a medical procedure. The enclosure comprises a plurality of rigid segments serially connected by a plurality of intersegment hinges, which are preferably living hinges The segments are disposed about a medical needle, folded upon each other during the medical procedure and extended at the end of the procedure to form a secure, substantially rigid safety shroud. During the procedure, the enclosure is folded and conveniently disposed about a proximal portion of the needle. At the end of the procedure, the enclosure is extended to protectively sheath and secure the needle in a substantially rigid structure formed in combination by the enclosure and the needle.

CONTINUATION

This application for patent is a continuation-in-part of U.S. patentapplication Ser. No. 08/744,108 filed Nov. 5, 1996 entitled SelfRetracting Medical Needle Apparatus and Methods, which is a continuationof U.S. patent application Ser. No. 08/595,802 filed Feb. 2, 1996 nowU.S. Pat. No. 565031 entitled Medical Syringe and Self Retracting NeedleApparatus, which is a continuation of U.S. patent application Ser. No.08/565,881 filed Dec. 1, 1995, now U.S. Pat. No. 5,616,135 issued Apr.1, 1997 entitled Self Retracting Medical Needle Apparatus and Methods,which is a continuation of U.S. patent application Ser. No. 08/455,514filed 31 May 1995, now U.S. Pat. No. 5,549,708 issued Aug. 27, 1996entitled Self Retracting Medical Needle Apparatus and Methods, which isa continuation of U.S. patent application Ser. No. 08/370,728 filed Jan.10, 1995, now U.S. Pat. No. 5,480,385 issued Jan. 2, 1996 entitled SelfRetracting Catheter Needle Apparatus and Methods, U.S. patentapplication Ser. No. 08/436,976 filed May 8, 1995, now U.S. Pat. No.5,487,734 issued Jan. 30, 1996 entitled Self Retracting Catheter NeedleApparatus and Methods, U.S. patent application Ser. No. 08/484,533 filedJune 7, 1995, now U.S. Pat. No. 5,542,927 issued Aug. 6, 1996 entitledSelf Retracting Syringe Needle Apparatus and Methods, each is acontinuation-in-part of Ser. No. 08/370,728 filed Jan. 10, 1995, nowU.S. Pat. No. 5,480,385, all disclosures of which are specificallyincorporated herein by reference.

FIELD OF INVENTION

This invention relates generally to safety devices for hollow boremedical needles and particularly to medical phlebotomy, syringe,butterfly and other hollow needle products which comprise protectiveneedle sheaths for securely shielding sharp medical needle tips afterbeing withdrawn from a patient. This invention more particularly relatesto sheaths or shrouds which are extended to a locked, needle-coveringposition after the needle is withdrawn from the patient.

PRIOR ART

Problems associated with inadvertent needle sticks are well known in theart of blood sampling, percutaneous medication injection and othermedical procedures involving uses of medical needles. Ever increasingattention is being paid to needle stick problems due to the contemporarysensitivity of exposure to AIDS, Hepatitis and other serious blood-bornediseases.

Commonly, procedures involving removing a needle from a patient requirea technician to use one hand to place pressure at the wound site wherethe needle is being withdrawn while removing the needle apparatus withthe other hand. It is common practice for a tending technician to givehigher priority to care for the wound than is given to disposal of aneedle. In the case of commonly used, non-safety devices such priorityeither requires convenience of an available sharps container withinready reach or another means for safe disposal without leaving thepatient's side. Providing adequate care is often compounded by patientcondition and mental state (e.g. in burn units and psychiatric wards).Under such conditions, it is often difficult, if not impossible, to takeappropriate procedures to properly dispose of a used, exposed needlewhile caring for a patient.

Widespread knowledge and history associated with needle care anddisposal problems have resulted in conception and disclosure of a largenumber of devices each of which represents an attempt to provide notonly a solution to the problem of needle sticks, but also a device whichis commercially viable (i.e. cost and price competitive with currentlyused non-safety devices).

Examples of disclosures of safety devices which protect needles bymoving a protective shield over a sharp end of a syringe or other hollowbore medical needle are found in U.S. Pat. No. 5,348,544, issued Sep.20, 1994 to Sweeney et al. (Sweeney), U.S. Pat. No. 5,246,428 issuedSep. 21, 1993 to Donald W. Falknor (Falknor), U.S. Pat. No. 5,256,153issued Oct. 26, 1993 to Lawrence W. Hake (Hake) and U.S. Pat. Nos.5,139,489 and 5,154,285, issued Aug. 18, 1992 and Oct. 13, 1992,respectively, to William H. Hollister (Hollister). There are many otherexamples of safety devices which retract needles into housings, however,this instant invention is more directly related to devices which extenda shield over a needle rather than to those which employ needleretraction.

Sweeney discloses a device comprising a guard which is manually,slidably movable along a needle canula from a position proximal to auser to a distal position where the needle tip is shielded. The devicecomprises a hinged arm which extends along the needle canula and whichis moved distally to collapse upon itself to extend the shield over thetip. Access to the tip is denied by a metallic clip. An alternativeembodiment is also disclosed by which the manual operation is augmentedby a spring A device based upon Sweeney is currently being distributedby Becton Dickinson and Company, Franklin Lakes, N.J. in which threeseparate parts (two injection molded and one metal clip) are used tomechanize the guard. Once the device is extended to shield a needle tip,it cannot be easily reset to recover use of the needle for a subsequentprocedure. Also, the hinged arm requires activation in the region of theneedle itself and comprises parts which are of a size which occasionallyimpedes a user's line of sight to insertion locations.

Falkner, and related disclosures, disclose devices comprising shieldswhich are automatically releasible to extend distally from a user tocover a needle. The devices comprise latch mechanisms which are manuallyswitched between unlatched and latched positions to free the needle foruse and lock the shield over the needle, respectively. Of course,position of the latch mechanism provides a visual interpretation of thesafety of the device (i.e. whether or not a latch is engaged), but thatis the only safety mechanism and a "missed" indicator of latch mechanismposition may be possible in stressful circumstances. When the latchmechanism is in the unlatched position, access to the needle is not onlypossible, but likely when the front of the device is impacted by a bodypart. In addition, the shield, though made of transparent material,covers a portion of an attached syringe body until fully extended andmay make reading portions of volume measurement indicia on the syringebody difficult to read with accuracy when the syringe is being used in atitrating application.

Hake is representative of disclosure of devices comprising a manuallyslidable guard which is disposed over a syringe body during a medicalprocedure involving a medical syringe needle and manually, slidablymoved distally into a needle guarding position usually at the end of theprocedure. Commonly users of such devices complain of difficulty ofseeing measurement indicia while the guard is disposed over the syringebody and of danger of inadvertent needle sticks while sliding the guarddistally to cover the needle. As well, it is generally difficult todetermine whether a guard is in a locked or unlocked state when itcovers the needle, making an additional possibility of inadvertentneedle stick.

Hollister discloses a needle protection device which may be used with adouble-ended needle assembly or with a simpler single needle system. Theprotection device comprises a substantially rigid housing flexiblyconnected to a container (for a vacuum tube sampling system) or to aneedle hub. To exercise the protection device, the rigid member ispivotally rotated into engagement with an exposed needle of thedouble-ended needle assembly and is securely affixed to the exposedneedle. A major drawback of the needle protection device of Hollister isthe size and position of the rigid housing. During use of an assembly orsystem in a medical procedure, length and position of the housing memberis considered by some to be inconvenient. A second drawback is therequirement either for two handed operation to pivot the housing toengage the needle or for the requirement to find and use a stablesupport surface against which the housing is pressed while the needle isswung into engagement with the housing. In a currently marketed format,an integral container holder version of the device disclosed byHollister comprises two injection molded parts which permit the housingto be rotated, as much as possible, out of the way during a medicalprocedure. Such a format requires five injection molded parts, includinga disposable needle assembly.

Generally, other than acceptance of the type of operation offered bysuch devices, commercial viability is dependent upon manufacturing cost.Purchase decisions in the area in which these devices are used are verycost sensitive. If gains in either improvement in safety or in laborsavings are not found to make a device sufficiently competitive withcontemporary competitive items, those devices are usually not found tobe commercially viable. In U.S. Pat. No. 5,480,385, from which thispatent filing continues, a medical needle safety phlebotomy apparatusdisclosing an integrally constructed barrel and medical needle assemblyfabricated and used as a single disposable unit is disclosed. By makingthe apparatus unitary including both barrel and needle, only fourinjection molded parts is required. Four injection molded parts in aneedle retraction safety device is emphasized therein as a significantfactor in cost reduction. Motivation for providing a cost competitiveself-retracting needle apparatus coupled with improved safety of use ofthe apparatus are the basis for conception of the instant inventionsdisclosed herein.

BRIEF SUMMARY AND OBJECTS OF THE INVENTION

In brief summary, the novel inventions disclosed herein dramaticallydiminish known major problems resulting from injury-related needlesticks which occur when needle tips are bared as medical needles arewithdrawn from a patient at the end of a needle insertion procedure,but, perhaps more important to general patient welfare, these inventionsprovide opportunity for fabrication of a very low cost safety needlesystem. Low cost is achieved by a dramatic reduction in injection moldedparts wherein a needle covering safety sheath is integrally molded withother parts such as a hub of the needle or a barrel segment of anintegral phlebotomy device.

In current standard non-safety phlebotomy devices, each needle assemblygenerally comprises a cannula having two sharpened ends to form amedical needle, a needle hub, a blood valve sheath (commonly called asnubber), two covers for protecting both sharp ends and a paper seal totape the two covers together and form an environmental protectivebarrier for the needle prior to use. Thus, with the barrel, six parts(including four injection molded parts) are currently used incontemporary, non-safety systems. In the phlebotomy application,employment of the instant inventions disclosed and claimed hereinproduces a safety phlebotomy device requiring only two injection moldedparts, and only five parts overall. This number of parts compares wellwith the number of parts required in barrel and needle assemblies whichmake up the contemporary non-safety systems and is much better whencompared against other safety phlebotomy systems.

Generally, basis for the invention is a foldable needle sheath whichfolds about a medical needle to permit access to the needle in a medicalprocedure. The sheath is hingeably attached to structure (e.g. a needlehub or phlebotomy barrel) at a point away from a sharpened needle tipwhich is later enclosed to protect a user. At the end of the procedure,the sheath is unfolded and extended away from the structure in thedirection of the needle tip to encase and thereby protect users fromcontact with the needle and its tip. To permit the sheath to unfoldabout the needle, each folded part of the sheath is serially constructedof a plurality of rigid segments. Each segment comprises an orificethrough which the needle passes and about which the segments rotatewhile the sheath is being extended. Each segment is connected to atleast one other segment by a hinge, which is preferably a molded, livinghinge, and comprises a channel into which the needle nests when thesheath is fully extended. At least one of the segments comprises a catchwhich securely captures the needle when it is disposed in the sheath.Once the sheath is extended and the needle so captured, the combinationof sheath and needle form a substantially rigid member which shrouds theneedle and its sharpened tip to provide safety from dangerous contactwith the tip and needle. All hingeable attachments are preferably livinghinges integrally and concurrently formed with other sheath parts.

Accordingly, it is a primary object to provide a manually actuatedsafety sheath for a medical needle which is a single molded part.

It is another object to provide a safety sheath which is integrallymolded with another part of a medical needle device (e.g. with aphlebotomy barrel or a medical needle hub).

It is a particularly important object to provide a sheath which is foldout-of-the-way in one state whereby a medical needle may be used in amedical procedure and which unfolded to combine with the medical needleto form a substantially rigid needle shrouding structure which protectsagainst inadvertent contact with a sharpened tip of the needle.

It is also an important object to provide a shroud which averts contactwith the needle along the length of the needle when the shroud isdisplaced to protect the needle and its tip.

It is an important object to provide an integral, self-contained, safetyphlebotomy system comprising a barrel and needle assembly and a safetyshroud, the entire system requiring but two injection molded parts.

It is another important object to provide an integral, self-contained,safety phlebotomy system which only requires five parts, including aneedle cover, a barrel, an adhesive label, a medical needle and needlehub.

These and other objects and features of the present invention will beapparent from the detailed description taken with reference toaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective of a barrel part which is in current use inblood sampling or phlebotomy.

FIG. 2 is an exploded perspective of parts which make up a needle systemwhich is in current use in blood sampling or phlebotomy, the needlesystem is in use in combination with the barrel part of FIG. 1.

FIG. 3 is a ready-to-use combination of the barrel part, seen in FIG. 1,securely, but releasible affixed to a needle assembly portion of theneedle system of FIG. 2, thus prepared for a phlebotomy procedure.

FIG. 4 is a side view of a phlebotomy needle.

FIG. 5 is a perspective of a pre-use state of one embodiment of theinstant invention disclosed herein.

FIG. 6 is a perspective of the embodiment of FIG. 5 with a front coverand a back label removed.

FIG. 7 is a section, taken along lines 7--7 of FIG. 6, illustrating aforepart which includes a safety sheath disposed about a medical needle.

FIGS. 7A-D are schematic representations of the safety sheath seen inFIG. 7 showing relative sheath positions as the sheath is displaced froman operational state to a needle enclosing state.

FIG. 8 is a section of the part seen in FIG. 7 disposed for needlecontainment.

FIG. 9 is a superior perspective of an as-molded part of a barrelportion of the embodiment seen in FIG. 5.

FIG. 10 is an inferior perspective of the part seen in FIG. 9.

FIG. 11 is a section taken along lines 11--11 in FIG. 10.

FIG. 12 is an as-molded perspective of another embodiment of the instantinvention.

FIG. 13 is a perspective of the embodiment seen in FIG. 14, but rotatedso parts hidden in FIG. 12 may be seen.

FIG. 14 is a perspective of a sheath assembly comprising a needle cover.

FIG. 15 is a rotated perspective of the sheath assembly of FIG. 14.

FIG. 16 is a perspective of the sheath assembly of FIG. 14 with needlecover removed.

FIG. 17 is a perspective of the sheath assembly of FIG. 16 wherein thesheath is extended toward enclosure of the needle.

FIG. 18 is a perspective of the sheath assembly of FIG. 16 wherein thesheath is fully extended to a rigid, needle-enclosing state.

FIG. 19 is a rotated perspective of the sheath assembly of FIG. 18.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

In this description, unless a specific object is referenced, the termproximal is used to indicate the segment of a device normally closest toa user (the clinician or technician who is treating a patient). In likemanner, the term distal refers to the other (away from the user) end.Reference is now made to the embodiments illustrated in FIGS. 1-19wherein like numerals are used to designate like parts throughout. Insome cases, parts having similar form and function to parts earliercited are enumerated with prime numerals of earlier cited parts.

Reference is now made to FIGS. 1-4 wherein parts and assemblies incommon current use in blood sampling or phlebotomy procedures areillustrated. A barrel part 10 is seen in FIG. 1. Generally, such barrelparts comprise a substantially hollow cylindrical portion 12 having apair of laterally extending wings 14 and 16 which are disposed about asample tube receiving orifice (not seen). A substantially closed end 18opposes the orifice and generally comprises a threaded opening 20.

An exploded view of a transport needle assembly 30 is seen in FIG. 2.Assembly 30 generally comprises a back cover 32, a needle assembly 34and a front cover 36. Needle assembly 34 comprises a posterior needlevalve 38, a double ended needle 40, a needle hub 42. The form of needle40 is best seen in FIG. 4 wherein needle 40 is seen to comprise a verysharp needle point or tip 44 and a non-coring needle tip 46. Needle tip44 is formed for efficient percutaneous entry into a patient's veinwhile tip 46 is formed to repeatedly pierce a pliable stopper on anevacuated sample tube without exacting a core from the stopper.

As part of a contemporary standard procedure, back cover 32 is removedfrom an unused transport assembly 30 to expose needle valve 38 and athreaded portion 48 of hub 42. Handling the remainder of assembly 30 byfront cover 36, portion 48 is inserted into opening 20 and secured byrotation thereto. Cover 36 is then removed to provide a procedure-readyblood sampling device 50, as seen in FIG. 3. Once a blood samplingprocedure has been completed, needle assembly 34 must be either removedfrom barrel 10 and placed into a sharps container or the entire device50 must be carefully discarded as a unit to assure an inadvertent stickby a contaminated needle does not occur.

It is widely known that often painful and sometimes tragic needle stickshave occurred before appropriate disposition of a contaminated needlehas been accomplished. All to often, care requirements dictate immediateattention being paid to a patient's needs before taking appropriateaction relative to discarding a contaminated needle. Even thoughthoughtful standards regarding care and handling of contaminated needlesare in place, inadvertent needle sticks occur all too often. In the faceof such occurrences, one might ask why safety products have not replacedthose currently commonly used. The answer to such a question likelycomprises conclusions reached after reviewing a number of factorsinvolved in device selection. Those factors include cost of individualsafety products compared to those currently commonly used, whether ornot ergonomic factors (such as required changes in procedure, transportand disposal) are acceptable and ease of implementation of safetyattributes. The above factors have been carefully considered by theinventor and are an important portion of the basis for the instantinvention disclosed and claimed herein.

Reference is now made to FIG. 5 wherein one embodiment of the inventionsis seen as unitary phlebotomy system 100. System 100 comprises a barrelassembly 110 with a needle 40 (hidden in FIG. 5) securely affixedthereto, a front needle protector 112 and a back seal 114. Barrelassembly 110 and needle 40 make up the primary functional device or unit(generally referenced by 115). Protector 112 and seal 114 are removedprior to commencing a blood sampling procedure, see FIG. 6.

Generally, protector 112 comprises a proximally disposed, hollowcylindrical portion 116 and a distally disposed needle cover part 118.Portion 116 comprises a section 120 which interfaces with an exteriorsurface 122 of barrel assembly 110. A sealing label or heat stake (notshown) may be disposed about the area of interface to form a protectiveseal for those parts of barrel assembly 110 which must be maintained ina sterile and tamper proof environment. Such labels are well known andin wide use in the medical needle and phlebotomy fields.

Barrel assembly 110 comprises a hollow barrel 124 which has a proximallydisposed opening 126 for ready insertion of an evacuated blood samplingtube (not shown). As is common today for barrels used for communicatingwith blood sampling tubes, barrel 124 also comprises a pair of wings 128and 130 which provide ease of handling when inserting and removing bloodsampling tubes from barrel 124.

Seal 114 is preferably releasibly, adhesively affixed to barrel assembly110 over opening 126 and provides a sterile barrier and tamper indicatoruntil removed from barrel assembly 110 for use. Preferably seal 114comprises a tab 132 which provides for facile removal to seal 114. Sealsfor similar purposes are well known and widely used in the medicaldevice field. To prepare system 100 for use in a medical procedure, seal114 and protector 112 are simply removed from barrel assembly 110, asseen in FIG. 6. Note that barrel assembly 110 has been rotated 180°relative to its position in FIG. 5. With cover removed, an extendableneedle sheath or shroud 140, generally numbered in other figures as140', is seen to be disposed about a medical needle 40. Note that, inthis embodiment, needle 40 is securely affixed to barrel 124. Attachmentof needle 40 to barrel 124 is disclosed in more detail hereafter.

Also in this embodiment, shroud 140 is hingeably affixed to a distalface 142 of barrel 124, preferably through a living hinge such thatbarrel 124 and shroud 140 are formed as a single molded part. Asimplified representation of shroud 140 is seen in FIG. 7. Some parts ofshroud 140 have been removed for clarity of presentation of shroud 140and needle 40 interaction. As seen in FIG. 7, shroud 140 generallycomprises a single proximal part, specifically numbered 150, for shroud140 and 150' for general reference, hinged to barrel 124 via a hinge 152(preferably a living hinge). It should be noted that, as is disclosedhereafter, shroud 140 may be hingedly affixed to any structurally soundpart relative to needle 40, such as a Luer fitting of a syringe, toprovide a general medical needle safety shroud or to a phlebotomybarrel.

Generally, a plurality of rigid members are serially hingedly affixed,one to another, to form shroud 140'. In the case of shroud 140, a middlemember 160 (generally referenced 160') is hingedly affixed to part 150(generally referenced by 150') by a hinge 162 (also preferably a livinghinge). Also in the case of shroud 140, a distal member 170 (generallyreferenced 170') is hingedly affixed to part 160 by a hinge 172(preferably a living hinge, as well). Note that each part 150, 160 and170 comprises a pathway 174 wherethrough needle 140 passes. Also in FIG.7, barrel 124 is seen to comprise a centrally disposed hub 180 in a face18' of barrel 124 through which needle 40 is inserted and securelyaffixed in an opening 20', making needle 40 a substantially rigid memberrelative to barrel 124.

Reference is now made to FIGS. 7A-D wherein a schematic representationof action of shroud 140 about needle 40 is seen in various steps. Onlythose primary parts of shroud 140 and needle 40 necessary forunderstanding movement of shroud 140, relative to needle 40, from anoperational state to a needle protecting state are seen in FIGS. 7A-D.As seen in FIG. 7A, part 150 comprises a superior proximal comer 182.Part 160 comprises a ledge member 184 (see FIG. 7), represented by line184' in FIGS. 7A-D which is disposed to communicate with needle 40 whenshroud 140 is caused to move as a result of a distally directed forcebeing applied to proximal corner 182. In similar manner, part 170comprises a ledge member 186 (see also FIG. 7), represented by line 186'in FIGS. 7A-D which is also disposed to communicate with needle 40 asshroud 140 is moved under application of force to comer 182. Note thatrigid part 160 may be divided into a superior part 190 and an inferiorpart 192, separated by line 184'. Similarly, rigid part 170 may bedivided into an inferior part 194 and a superior part 196, separated byline 186'. Further, part 160 comprises a superior face 200 comprising aconnection to hinge 162 and an inferior face 202 comprising a connectionto hinge 172. Likewise, part 170 comprises an inferior face 204 having aconnection to hinge 172 and a superior face 206 which ultimately formsthe most distal portion of shroud 140.

Intermediate dispositions of parts 150, 160 and 170 as continuingdistally directed force is applied to comer 182 are seen in FIGS. 7B and7C. Successively, distal application of force causes, in sequence,disposition of parts 150, 160 and 170 of shroud 140 as seen in FIG. 7Band subsequently as seen in FIG. 7C. Note that, as line 184' (ledgemember 184) is moved into contact with needle 40, Rotation of part 150relative to hub 180 is translated into rotation of part 160 throughhinge 162. Consequently, part 170 is directed superiorly through hinge172 until line 186' (ledge member 186) is raised to contact needle 40.Upon contact of line 186' against needle 40, part 170 is rotated inclockwise fashion to extend face 206 to be distally disposed relative toneedle tip 44. As seen in FIG. 7D, further rotation of part 150 to asubstantially parallel disposition relative to needle 40 results insimilar disposition of parts 160 and 170. To assure forces directed uponcomer 182 always result in extension of part 170, part 170 should notform an angle (indicated by arc and arrow 188) of equal to or less than90°. An extended foot 189, seen in FIG. 7, provides extension whichfunctions to provide a linear offset which results in an angular bias toprotect against binding when angle 188 is less than 90°. Further,protruding latches 210 and 212, described hereafter, may be used forfurther bias. A stop 221, seen protruding from face 142 of barrel 124provides a similar bias, retarding part 160 from binding against needle40 as comer 182 is displaced distally.

Latching of one or more parts, for example part 150 or 160, to needle 40causes needle 40 to be enclosed in a substantially rigid safetyenclosure. Such an enclosure requires no clip or spring retention astaught by Sweeney. As one who is skilled in mechanical and geometricarts understands, a shroud may be constructed using two or more hingedparts depending upon that needle length and part length required toextend a safety cover about a needle tip.

A partial cross section of barrel assembly 110 with shroud 140 disposedas seen in FIG. 7D is provided in FIG. 8. Note a protuberance 208superiorly disposed upon part 150 at corner 182 provides a noticeablesite upon which to exert a downwardly and distally directed force tocause shroud 140 to extend. Note also, a first latch 210 which catchesand securely affixes needle 40 in the safety of recesses of shroud 140.Part 160 comprises a second latch 212 which also catches needle 40 tofurther assure rigidity of the combination formed by shroud 140 andneedle 40. Form of exemplary latches having form and function similar tolatches 210 and 212 are disclosed in detail hereafter.

FIGS. 9 and 10 show superior and inferior perspectives, respectively, ofbarrel assembly 110 before needle attachment. Barrel assembly 110 inFIGS. 9 and 10 are in an "as-molded" state. Barrel assembly ispreferably injection molded in such a state using polypropylenesynthetic resinous material, although other material which supports bothfabrication living hinges and which has sufficient materialcharacteristics to perform adequately as a hub for needle 40 and aphlebotomy barrel may be used.

Note that parts 150, 160 and 170, when aligned in a common plane,comprise a common channel or pathway 220 for needle 40. Hingespreviously referenced as 162 and 172 are each seen to be double hingepairs, 162' and 162" and 172' and 172', respectively. The double hingepairs are disposed on each side of pathway 220 to permit folding andunfolding of shroud 140 without interfering with needle 40. Hinge 152 issimilarly comprised of a hinge pair 152' and 152". As best seen in FIG.10, part 170 comprises a raised section 230, forming a deep well 232 fortip 44 when needle 40 is extended to provide further protection againstinadvertent access to needle tip 44 when shroud 140 is elongated to itsneedle safety state.

As seen in FIGS. 9 and 10, hub 180 is disposed in line with pathway 220.Attention is now drawn to FIG. 9 wherein part 170 is seen to comprise acentrally disposed orifice 240. Part 160 is seen to comprise a similarlydisposed orifice 242. In combination a barrel face 18' of barrel 124 andpart 150, form an opening 244 about hub 180. To form a usable assembly,shroud 140 is folded as seen in FIG. 6 and needle 40 is inserted throughorifices 240 and 242 and opening 244 (along pathway 174) into hub 180and securely affixed thereto. Affixing of needles within hubs is wellknown to those skilled in manufacturing processes in hollow medicalneedle device assembly. Note that insertion of needle 40 throughorifices 240, 242 and opening 244 involves needle 40 as an active memberin the process of extending shroud 140.

Reference is now made to FIG. 11 wherein latch 210 is seen in crosssection. Latch 210 is displaceable when it comes in contact with needle40. For this purpose, latch 210 preferably comprises an inclined outwardsurface 246 slanting toward an opening 248 which elasticallyaccommodates entry and final disposition below latch head 250. Latch 212is similarly formed.

A presently preferred embodiment of a shroud portion (shroud 140') ofthe instant invention is provided in FIGS. 12-19. Some parts of thisembodiment having substantially the same function as parts numberedabove will be identified with primes of numbers used above for clarityof association of previously described function. As-molded parts ofshroud 140' are seen in FIGS. 12 and 13. Note that shroud 140' comprisesa proximally disposed connecting tab 300. Tab 300 represents a linkingmember to other parts which are not shown, but which would be molded aspart of an integrally molded system. Such other parts may be aphlebotomy barrel, a luer fitting or other connecting part. Shroud 140of FIGS. 12 and 13 also comprises a needle hub 180, a proximal hingedpart 150', a centrally disposed hinged part 160' and a distal hingedpart 170'.

Similar to previously disclosed embodiments, parts 150', 160' and 170'are each individually substantially rigid structures. Part 150' isconnected to part 160' via hinges 162' and 162". Part 160' is connectedto part 170' via hinges 172' and 172".

Part 150' is also hingeably connected to part 300, but the hinges arenot shown in FIGS. 12 and 13. Part 150' comprises hub 180, a bulbus orbutton part 208' disposed at comer 182, and a pair of side clips 302 and304. Hub 180 comprises an orifice 20' into which a needle 40 isinstalled and secured to form an assembled needle system which is readyfor use in a medical procedure. Each side clip 302 and 304 transverselyextends outward from part 150' in a direction which permits contact withpart 160' as part 160' is closed upon part 150' as constrained by hinges162' and 162". Each clip 302 and 304 comprises an inwardly facingprotuberance 306 and 308, respectively. Function and purpose of clips302 and 304 will be disclosed in detail hereafter.

Part 160' comprises a pair of latch sites, 310 and 320. Each latch sitecomprises an opposing pair of latches, generally numbered 330. Eachlatch comprises an inwardly protruding and sloping catch member 332affixed to a riser 334 which is integrally attached to a rail member336. Generally, each latch 330 functions as previously disclosed forlatch 210. However, in the case of each latch 330, spreading isfacilitated by lateral displacement of both riser 334 and rail member336 when a needle 40 is forced toward entrapment in part 160'. It ispreferred that engagement of needle 40 by latches 330 be accompanied bya snapping sound to provide an audible indication of a safe state havingbeen achieved as needle 40 is captured in shroud 140'.

Part 170' comprises a needle tip 44 protecting plate 340, a raisedsection 230' and a closed end 206'. Section 230' provides a raised,physical barrier to protect a user from inadvertent contact with aneedle tip 44 after needle 40 is captured in shroud 140'. Each part150', 160' and 170' comprises at least one structural cross member,generally numbered 350, to assure rigidity of each of the parts. Notethat the cross members are disposed to allow clearance for needle 40 asshroud 140' is unfolded.

Reference is now made to FIGS. 14-16. Assembly of a medical-procedureready device is made by simply securely affixing a needle 40 into hub180, with parts 150', 160' and 170' folded as seen in FIG. 16. For amore compact fold where part 170' is more parallel with part 160',consideration must be given to assuring that part 170' separates frompart 160' when shroud 140' is extended. For that assurance, part 170'must be continuously apart from part 160' at an angle which insuresclosing angles of intersection between part 170' and needle 40 arealways disposed in a non-binding manner. To accomplish this, either anappendage (not shown) may be added to bias parts 160' and 170' apart oran outwardly extending foot or skid, such as foot 189, seen as anexample in FIG. 7, may be added to part 170' along line 186' (see FIG.15 for position of line 186').

A protective cover 360 for needle 40 which is disposed through pathway174 formed in combination by parts 150', 160' and 170' is seen in FIGS.14 and 15. Cover 360 comprises an elongated, hollow tubular member 362,an open proximal end 364 and a closed distal end 366. With cover 360 inplace, cover 360, shroud 140' and needle 40 and other parts which may beconnected to part 300 make up a complete needle 40 protective system. Itis important to note that, to make space for insertion of cover 360along pathway 174 through parts 150', 160' and 170' lines 186' (bestseen in FIG. 15) and 184' (best seen in FIG. 14) must be offset fromneedle 40 to permit passage of cover 360 therethrough.

Cover 360 is removed to bare needle 40 as seen in FIG. 16 beforebeginning a medical procedure. At the end of the procedure, shroud 140'is extended to engage needle 40 and form a substantially rigid bodycomprised of needle 40 and shroud 140'. In the extending process, asdisclosed previously, rotation of part 150' causes part 160' to rotatewhich, in turn, causes part 170' to rotate. By their structuralgeometry, all parts (150', 160', 170') arrive in line (in a singleplane) at the same time. However, the offsets mentioned above delayrotation of part 160' relative to part 150' and of part 170' relative topart 160'. As shroud 140' is extended by pressing distally upon corner182 to rotate part 150', rotation of part 160' is delayed until line184' comes into contact with needle 40. Subsequently, rotation of part170' begins when line 186' comes into contact with needle 40. For thesereasons, part 170' rotates more rapidly than part 160' about needle 40at angles of engagement of latches 330 at sites 310 and 320.

An intermediate view of an extending shroud 140' is seen in FIG. 17.Initial rotation of part 150' frees part 160' from releasiblecontainment of clips 302 and 304. Part 160' is displaced by rotation ofpart 150' until line 184' is in contact with needle 40. Subsequentrotation of part 160' displaces line 186' toward needle 40, but contactbetween line 186' and needle 40 must occur before part 170' rotates.

FIGS. 18 and 19 provide opposite side perspectives of shroud 140' fullyextended to enclose needle 40. Note that all latches 330 are engagedabout needle 40. These engagements occur, preferably with an audiblesnap, as part 160' is rotated into parallel disposition relative to thelong axis of needle 40. Movement of any part of shroud 140' is limitedby the tightest latch containment and "play" in the hinges, especiallyhinges 172' and 172". Therefore, it is important to hold tolerances oflatches and hinges to reasonably tight limits to assure stability of ashroud 140'/needle 40 combination. Access to a shroud 40 protectedneedle tip 44 is restricted by a combination comprising thesubstantially fixed length of shroud 140' relative to needle 40,disposition of protecting plate 340 on one side of shroud 140' andheight and size of opening in raised section 230' on the other side.

The inventions disclosed herein may be embodied in other specific formswithout departing from the spirit or essential characteristics thereof.The present embodiments are therefore to be considered in all respectsas illustrative and not restrictive, the scope of the invention beingindicated by the appended claims rather than by the foregoingdescription, and all changes which come within the meaning and range ofequivalency of the claims are therefore intended to be embraced therein.

What is claimed and desired to be secured by Letters Patent is: 1.Integral phlebotomy apparatus requiring but two injection molded parts,said apparatus comprising:a first molded part comprising a cylindricalbarrel assembly having an opening at a first end for receiving anevacuated blood sampling tube, a needle hub disposed at an otherwisesubstantially closed second end wherein a hollow bore medical cannula isdisposed and securely affixed to provide a fluid flow pathway to saidevacuated blood sampling tube, and a foldable sheath hingeably affixedto said barrel assembly; a hollow bore cannula disposed through saidsheath, which is folded to provide a pathway therethrough, and securelyaffixed in said needle hub and having a sharpened tip on at least an endof the cannula to form a percutaneous insertion point; a second moldedpart comprising an elongated internal pathway for protective cover forsaid needle and a means for being releasibly attached to said firstmolded part; said sheath comprising a plurality of seriallyinterconnected substantially rigid segments each of which isinterconnected to at least one adjacent segment by a living hinge, atleast one segment comprising two opposing sides wherethrough access isprovided to an open pathway, through which said cannula passes to forman axis of intersection between said cannula and at least one segment,and a channel in which the cannula is fully disposed when the sheath islinearly extended, said sheath and said hinges being disposed to permitfolding of the sheath proximal to the cylindrical barrel in a firststate to permit usable access to said cannula and said sharpened tip ina medical procedure, and extending of the sheath along said cannula to aplanar disposition about said cannula whereat the cannula is disposedalong the channel, said sheath further comprising at least one latchingmember which catches and securely affixes the cannula relative to thesheath, said sheath and cannula thereby forming a substantially rigidbody which protectively encloses said sharpened tip and denies accessthereto.
 2. Integral phlebotomy apparatus according to claim 1 wherein asegment which encloses said sharpened tip comprises a closure of itschannel distal from the barrel and sharpened tip.
 3. Integral phlebotomyapparatus according to claim 1 wherein the segment closest to saidbarrel assembly comprises a button which when disposed downwardlyextends that segment and the other segments of said sheath along andabout said cannula and causes the at least one latching member tosecurely affix the sheath relative to the cannula.
 4. Integralphlebotomy apparatus according to claim 1 wherein said at least onelatching member comprises two latching members.
 5. Integral phlebotomyapparatus according to claim 1 wherein a sheath which encloses saidsharpened tip comprises an increase in thickness above the channel inthe sheath which further protects against contact with the sharpenedtip.
 6. A method for manufacturing an integral phlebotomy assemblycomprising the steps of:molding within a single injection mold a firstinjection molded part comprising a cylindrical barrel assembly having anopening at a first end for receiving an evacuated blood sampling tube, ahub disposed at an otherwise substantially closed second end wherein ahollow bore medical needle is disposed and secured to provide a fluidflow pathway to said evacuated blood sampling tube, and an articulatedneedle sheath hingeably affixed to said barrel assembly, said sheathcomprising a plurality of linearly hingeably affixed segments, at leastone segment comprising a passageway wherethrough said needle passes;folding said articulated needle sheath against said barrel assembly;securely affixing a hollow bore needle into said hub such that saidneedle is disposed through and securely affixed in said needle hub andslidably disposed through each at least one segment passageway, saidneedle having a sharpened tip on at least an end of the cannula to forma transcutaneous insertion point; and releasibly attaching a secondmolded part comprising an elongated internal pathway for protectivecover for said needle to said first molded part.
 7. A safety apparatusfor sheathing a medical needle, said apparatus comprising:a hollow borecannula securely affixed in a hub and having at least one sharpened tipto form the medical needle; a molded part hingeably joined to said hub,said part comprising an elongated sheath which comprises a plurality ofserially interconnected substantially rigid segments each of which isinterconnected to at least one adjacent segment by a living hinge, atleast one segment comprising an open orifice, through which said cannulapasses to form an axis of intersection about the cannula, and a channelin which the cannula is disposed when the sheath is linearly extended,said sheath and said hinges being disposed to permit folding of thesheath about the cannula in a first state to permit usable access tosaid sharpened tip in a medical procedure and extending of the sheath toa substantially planar disposition along said cannula whereat thecannula is disposed along the channel, said sheath further comprising atleast one latching member which catches and securely affixes the cannularelative to the sheath, said sheath and cannula, in combination, therebyforming a substantially rigid body which protectively encloses saidsharpened tip and denies access thereto.
 8. Safety apparatus accordingto claim 7 wherein a segment which encloses said sharpened tip comprisesa closure of its channel distal from the barrel and sharpened tip. 9.Safety apparatus according to claim 7 wherein the segment closet to saidhub comprises a button which, when disposed downwardly extends thatsegment and the other segments of said sheath along and about saidcannula and causes the at least one latching member to be securelyaffixed relative to the cannula.
 10. Safety apparatus according to claim7 wherein said at least one latching member comprises two latchingmembers.
 11. Safety apparatus according to claim 7 wherein a sheathwhich encloses said sharpened tip comprises an increase in thicknessabove the channel in the sheath which further protects against contactwith the sharpened tip.
 12. Safety apparatus according to claim 7wherein said hub and said sheath are, in combination, a single, integralmolded part.
 13. A safety apparatus for sheathing a medical needle, saidapparatus comprising:a hollow bore cannula securely affixed in a hub andhaving at least one sharpened tip to form the medical needle; a parthingeably joined to said hub, said part comprising an elongated sheathwhich comprises a plurality of serially interconnected substantiallyrigid segments each of which is interconnected to at least one adjacentsegment by an intersegment hinge, at least one segment comprising anopen orifice, through which said cannula passes to form an axis ofintersection about the cannula, and a channel along which the cannula isdisposed when the sheath is linearly extended, said sheath and saidhinges being disposed to permit folding of the sheath about the hub in afirst state to permit usable access to said sharpened tip in a medicalprocedure and extending of the sheath to a substantially planardisposition along said cannula whereat the cannula is disposed along thechannel, said sheath further comprising at least one latching memberwhich catches and securely affixes the cannula relative to the sheath,said sheath and cannula, in combination, thereby forming a substantiallyrigid body which protectively encloses said sharpened tip and deniesaccess thereto.
 14. Safety apparatus according to claim 13 wherein asegment which encloses said sharpened tip comprises a closure of itschannel distal from the barrel and sharpened tip.
 15. Safety apparatusaccording to claim 13 wherein the segment closest to said hub comprisesa button which, when depressed to dispose that segment onto saidcannula, extends said sheath along and about said cannula and causes theat least one latching member to be securely affixed to the cannula. 16.Safety apparatus according to claim 13 wherein said at least onelatching member comprises two latching members.
 17. Safety apparatusaccording to claim 13 wherein a segment which encloses said sharpenedtip comprises an increase in thickness above the channel in the sheathwhich further protects against contact with the sharpened tip. 18.Safety apparatus according to claim 13 wherein said hub and said sheathare, in combination, a single, integral molded part.
 19. A method forenclosing a sharpened medical needle in a safety shield comprising thesteps of:providing a hollow bore cannula securely affixed in a hub, saidcannula having at least one sharpened tip to form the medical needle,and a part hingeably joined to said hub, said part comprising anelongated sheath which comprises a plurality of serially interconnectedsubstantially rigid segments at least one of which is interconnected toat least one adjacent segment by an intersegment hinge, each segmentcomprising an open orifice, through which said cannula passes to form anaxis of intersection about the cannula, and a channel in which thecannula is disposed when the sheath is linearly extended, said sheathand said hinges being disposed to permit folding of the sheath about thehub in a first state to permit usable access to said sharpened tip in amedical procedure and extending of the sheath to a substantially planardisposition along said cannula whereat the cannula is disposed along thechannel, said sheath further comprising at least one latching memberwhich catches and securely affixes the cannula to the sheath, saidsheath and cannula, in combination, thereby forming a substantiallyrigid body which protectively encloses said sharpened tip and deniesaccess thereto; displacing said sheath about said hub and cannula in acompact state such that said needle tip is accessible for a medicalprocedure; at the end of the medical procedure, displacing a proximalsegment of said sheath to unfold segments of the sheath until said atleast one latching member is latched relative to said cannula to formthe substantially rigid body and thereby protectively enclose and denyaccess to said at least one sharpened tip.